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Recruiting NCT06960083

Transcranial Magnetic Stimulation in Misophonia

No phase Interventional Misophonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial Magnetic Stimulation (TMS).
Who it may be relevant to
Registry conditions: Misophonia. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Transcranial Magnetic Stimulation Approach to Treat Misophonia

Overview

The purpose of the project is to assess the efficacy of parietal transcranial magnetic stimulation in misophonia. N=60 participants will undergo two transcranial magnetic stimulation sessions: one inhibitory and another excitatory. During both sessions, the parietal region will be stimulated. Participants will perform computerized tasks immediately before and after the stimulation, while EEG, heart rate, and skin temperature will be recorded. These recordings will be used to assess if TMS can be used to improve tolerance to misophonia triggers.

Interventions

  • Other Transcranial Magnetic Stimulation (TMS)
    Transcranial Magnetic Stimulation (TMS) is an FDA-approved non-invasive brain stimulation technology. It is currently used for treating depression. Applications to other disorders such as OCD and anxiety using TMS are currently under investigation. TMS will be administered for 25 minutes.

Primary outcome measures

  • Unpleasantness Rating Scale [Time frame: after each session, 72 hours apart (each session is 2 hours)]
Secondary outcome measures (6)
  • Heart Rate [Time frame: after each session, 72 hours apart (each session is 2 hours)]
  • Skin Conductance Response [Time frame: after each session, 72 hours apart (each session is 2 hours)]
  • EEG P1-N1-P2 Complex Peak Amplitude [Time frame: after each session, 72 hours apart (each session is 2 hours)]
  • EEG P1-N1-P2 Complex Peak Latency [Time frame: after each session, 72 hours apart (each session is 2 hours)]
  • EEG Frequency Band Amplitude [Time frame: after each session, 72 hours apart (each session is 2 hours)]
  • EEG Frequency Band Inter-Trial Coherence [Time frame: after each session, 72 hours apart (each session is 2 hours)]

Eligibility criteria

Inclusion criteria

  • Hypersensitive to presence of a specific sound, which may be accompanied by irritation, anger/outbursts, or fear.
  • Must be between the ages of 18 - 55.
  • Must be fluent in English since the study's instructions, surveys, and tasks will be in English.

Exclusion criteria

  • Epilepsy or previous episode of convulsion or seizure.
  • Previous episode of fainting spell or syncope.
  • Head trauma.
  • Hearing problems.
  • Cochlear implant.
  • Metal in the brain, skull, or anywhere else in the body (e.g., splinters, fragments, clips, etc.).
  • Implanted neurostimulator (e.g., DBS, epidural/subdural, VNS).
  • Presence of cardiac pacemaker or intracardiac lines.
  • Presence of medication infusion device.
  • Use of pro-convulsant or epileptogenic medications.
  • Pregnancy. The risks associated with TMS exposure during gestation have not been studied extensively. We wish to safeguard the health of potential participants and their children.
  • Lactation. The risks associated with TMS during lactation and its effects on infant development have not been studied. We wish to safeguard the health of potential participants and their children.
  • Presence of Mania, Psychosis, Antisocial Personality Disorder, Borderline Personality Disorder, and Suicidal Ideation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mount Sinai West — New York

Identifiers

NCT: NCT06960083 · STUDY-24-00527 · 24-0489-00001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗